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Combination Chemotherapy With or Without Gemtuzumab Ozogamicin or Tipifarnib in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00454480
Recruitment Status : Completed
First Posted : March 30, 2007
Last Update Posted : August 26, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with gemtuzumab ozogamicin or tipifarnib may kill more cancer cells.

PURPOSE: This randomized phase II/III trial is studying different combination chemotherapy regimens to compare how well they work when given with or without gemtuzumab ozogamicin or tipifarnib in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndromes.

Condition or disease Intervention/treatment Phase
Leukemia Myelodysplastic Syndromes Biological: alemtuzumab Drug: arsenic trioxide Drug: azacitidine Drug: busulfan Drug: clofarabine Drug: cytarabine Drug: daunorubicin hydrochloride Drug: fludarabine phosphate Drug: gemtuzumab ozogamicin Drug: melphalan Drug: tipifarnib Genetic: DNA methylation analysis Genetic: cytogenetic analysis Genetic: gene expression analysis Genetic: mutation analysis Other: diagnostic laboratory biomarker analysis Other: immunologic technique Procedure: allogeneic hematopoietic stem cell transplantation Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Programme of Treatment Development for Older Patients With Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome
Study Start Date : August 2006
Actual Primary Completion Date : August 2012

Primary Outcome Measures :
  1. Overall survival
  2. Achievement of complete remission and reasons for failure
  3. Duration of remission, relapse rates, and deaths
  4. Hematological and nonhematological toxicity
  5. Supportive care requirements (and other aspects of health economics)

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of 1 of the following:

    • Acute myeloid leukemia (AML) meeting the following criteria:

      • De novo or secondary AML
      • No acute promyelocytic leukemia
    • High-risk myelodysplastic syndromes (> 10% marrow blasts; refractory anemia with excess blasts-2)
    • No blast transformation of chronic myeloid leukemia
  • Patients ≤ 60 years of age may be eligible provided they are considered unfit for clinical trial MRC-AMLI5


  • Not pregnant or nursing
  • AST and ALT ≤ 2 times upper limit of normal (ULN) (for patients receiving gemtuzumab ozogamicin)
  • Bilirubin ≤ 2 times ULN (for patients receiving gemtuzumab ozogamicin)
  • Creatinine normal (for patients receiving clofarabine)
  • No other concurrent active malignancy except basal cell carcinoma


  • No prior cytotoxic chemotherapy for AML

    • Hydroxyurea or similar low-dose therapy to control WBC count prior to initiation of intensive therapy allowed
  • No concurrent enzyme anticonvulsants, including phenytoin, phenobarbital, primidone, carbamazepine, or oxcarbazepine (for patients receiving tipifarnib)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00454480

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Sponsors and Collaborators
The University of New South Wales
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Study Chair: Alan K. Burnett, MD, FRCP University Hospital of Wales
Layout table for additonal information Identifier: NCT00454480    
Other Study ID Numbers: CDR0000526121
First Posted: March 30, 2007    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: August 2008
Keywords provided by National Cancer Institute (NCI):
untreated adult acute myeloid leukemia
de novo myelodysplastic syndromes
secondary acute myeloid leukemia
secondary myelodysplastic syndromes
previously treated myelodysplastic syndromes
refractory anemia with excess blasts
adult acute basophilic leukemia
adult acute eosinophilic leukemia
adult acute megakaryoblastic leukemia (M7)
adult acute minimally differentiated myeloid leukemia (M0)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myeloblastic leukemia without maturation (M1)
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myelomonocytic leukemia (M4)
childhood myelodysplastic syndromes
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Fludarabine phosphate
Arsenic Trioxide
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents